Apparatus and Method of Supporting Patient Tissue

ABSTRACT

A perianal support device is provided that is configured to inhibit the formation and/or progression of tissue damage in the perianal region of the body. A method is provided to apply the perianal support device to patients during childbirth to inhibit the formation and/or progression of tissue damage in the perianal region of the body.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the priority of U.S. Provisional PatentApplication Ser. No. 60/746,283 filed May 3, 2006, the contents of whichare hereby incorporated by reference in its entirety. U.S. patentapplication Ser. No. 11/197,627 filed Aug. 5, 2005 entitled Method,Apparatus and System for Preventing or Reducing the Severity ofHemorrhoids commonly assigned to the present applicant is herebyincorporated by reference in its entirety.

BACKGROUND

The disclosed embodiments relate to a method and apparatus forinhibiting perianal tissue damage. The child birthing process is atraumatic event for a women's body and can result in tissue damage; suchas fissures, tears and bulging, in and around the anus as a result ofpushing the baby into and/or through the birthing canal. Even when labordoes not result in a vaginal delivery, the process of pushing duringlabor may also result in the development of or increase in severity ofhemorrhoids. Current birthing techniques do not provide an apparatus ormethod for supporting the soft perianal tissues near the anal orifice.

Thus, there is a need for devices and methods that provide support tothe perianal tissues. In some aspects, these devices and methods may beuseful in preventing or reducing the severity of hemorrhoids and othertissue damage, during the child birthing process.

SUMMARY

In one embodiment, a system for perianal tissue support is provided. Thesupport includes a support body having a midline perianal tissuepressure member with a lateral anchoring assembly joined to the supportbody and extending away from the support body in a directionsubstantially transverse to the midline of the pressure member. In afurther aspect, the anchoring assembly includes a mechanism for applyingforce to the support body to compressively load the pressure memberagainst the perianal tissue of the patient.

In another embodiment, a support device for use on a patient isprovided. The support device comprises a body configured for at leastpartial placement in the cleft of the buttocks, the cleft having a depthmeasured in the sagittal plane of the patient. The body includes acontact surface configured to support a perianal region and acompression member extending from the body. The compression member has alength in the saggital plane that is greater than the depth of thegluteal cleft.

In still a further embodiment, a method is provided. The method includesproviding a support member having a pressure surface configured forengaging the perianal area of a patient and an elongated compressionmember. The method includes positioning the pressure surface proximatethe perianal area of a patient with the compression member extendingoutwardly beyond the crown of the buttocks, and applying pressure to thecompression member to direct pressure through the pressure surfaceagainst the perianal area of the patient. In one aspect, the methodincludes securing at least the compression member to inhibit movement.In still a further aspect, the securing includes adhering a portion ofan elongated member to the patient.

In yet another embodiment, there is provided a kit for applying to theperianal region of a patient. In one aspect, the kit includes a perianalsupport member and an anchoring system. In a further aspect, theanchoring system includes a mechanism for applying force to the perianalsupport member to compressively load the perianal tissue of the patient.In a further aspect, the kit includes a treating compound.

In one embodiment, a perianal support device for a patient is provided.The device comprises a perianal support body having a pressure surfaceconfigured to engage perianal tissue and a system for applying pressure.The pressure applying system has a first portion engagable to thesupport body and a second portion extending away from the support body.The pressure applying system is configured to force the pressure surfaceto press against the perianal tissue.

In a further embodiment, a method is provided for fixing a perianalsupport device to a patient to compressively load the perianal tissue.

Further aspects, forms, embodiments, objects, features, benefits, andadvantages of the present disclosure shall become apparent from thedetailed drawings and descriptions provided herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one aspect of an apparatus according toa first embodiment;

FIG. 2 is a perspective view, opposite to the view of FIG. 1, of theapparatus of FIG. 1;

FIG. 3 is a partial perspective bottom view of the apparatus of FIG. 1affixed to a patient during child delivery;

FIG. 4 is a partial cross sectional top view of FIG. 3, showing stylizedpatient anatomy and the applied apparatus;

FIG. 5 is a perspective view of another embodiment of the presentinvention;

FIG. 6 is an end view of the apparatus of FIG. 5;

FIG. 7 is a side view of the apparatus of FIG. 5;

FIG. 8 is a perspective view of one aspect of the base of the apparatusof FIG. 5;

FIG. 9 is a perspective view of a further embodiment of the presentinvention;

FIG. 10 is an end view of the apparatus of FIG. 9;

FIG. 11 is a side view of the apparatus of FIG. 9;

FIG. 12 is a first perspective view of a still a further embodimentaccording to another aspect of the present invention;

FIG. 13 is a second perspective view, of the embodiment of FIG. 12;

FIG. 14 is a perspective view of another embodiment according to afurther aspect of the present invention;

FIG. 15 is a top view of the embodiment of FIG. 14;

FIG. 16 is an end view of the embodiment of FIG. 14;

FIG. 17 is a perspective view of a system according to one aspect of thepresent invention;

FIG. 18 is a perspective view of a further embodiment according toanother aspect of the present invention;

FIG. 19 is a partial cross sectional top view of the embodiment of FIG.18 applied to a patient with stylized depiction of the patient anatomy;and

FIG. 20 is a partial perspective view of a device according to thepresent invention applied to a patient during child delivery.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the disclosure is intended. Any alterations and furthermodifications in the described devices, instruments, methods, and anyfurther application of the principles of the disclosure as describedherein are contemplated as would normally occur to one skilled in theart to which the disclosure relates. In particular, it is fullycontemplated that the features, components, and/or steps described withrespect to one embodiment may be combined with the features, components,and/or steps described with respect to other embodiments of the presentdisclosure.

Referring now to FIGS. 1-4, a support system according to one embodimentof the present invention is illustrated in association with the perianaltissue of a patient 10. In FIG. 4, the patient 10 is shown in partialcross section to illustrate a portion of the rectum 54, anal canal 36,anal orifice 38, internal venous plexus 29, pectinate line 37 (alsoknown as the dentate line), and external venous plexus 28. The patient'sbuttocks 14 and 15 are shown with the crown of the buttocks 16 and 17,respectively, laterally adjacent the perianal region 26. The glutealcleft 13 (FIG. 3) is between buttocks 14 and 15. The buttocks 14 and 15extend laterally beyond crowns 16 and 17 toward lateral flanks 18 and19, respectively. The crowns 16 and 17 of each buttocks 14 and 15 inessence define the midline of each leg and the lateral flanks 18 and 19are the area lateral of the leg/buttocks midline. The lateral flanks 18and 19 may include, for example but without limitation, all or a portionof the lateral buttocks, hips, or upper thigh of the patient.

During the child birthing process, contractions during labor move achild 12 into the birth canal and ultimately, for a vaginal delivery,through the vaginal opening 11, as shown in FIG. 3. In an alternativebirthing process, labor is commenced to move the child 12, but for avariety of reasons, the delivery does not occur vaginally but insteadcaesarian delivery is performed through a surgical opening in themother's abdomen. During the birthing process, tremendous pressure isexerted in an effort to move the child toward delivery. At least some ofthis pressure is exerted against the tissues adjacent the anal orifice38 in the perianal region 26. The result of these forces is that bloodvessels near the anus, such as those in the external venous plexus 28,may bulge or rupture causing hemorrhoids or increasing their severity.Still further, other tissues in the perianal region 26 adjacent the anusmay distend outwardly opposite arrow A1 in FIG. 4 causing lacerationssuch as tearing around the vaginal opening or fissures from the anus. Inaddition to the blood loss, pain, and discomfort, these lacerations canbe a location for infections in the mother. The present inventionprovides devices to support the perianal tissues during the birthingprocess without interfering with the birthing canal or vaginal opening11 and/or allowing easy removal to access the perianal region 26. Stillfurther, methods are provided to support the perianal tissue to inhibitdamage to the tissue near the anal orifice 38, both internally andexternally, to inhibit, for example but without limitation to otheractions, the formation or advancement of external hemorrhoids and/or toinhibit the formation or advancement of lacerations of the perianaltissues.

Referring to FIGS. 1 and 2, there is shown an embodiment of one aspectof a tissue support device 20 according to the present invention.Support device 20 includes a base 22 having a raised portion 24extending generally along contact axis 48. In the illustratedembodiment, the raised portion 24 defines a partial cylinder having acurved pressure surface 30 oriented to extend along contact axis 48between the posterior end 31 and the anterior end 32. A first flange 60has a first end portion 62 joined to the raised portion 24 and anopposing second end portion 64. An opposing second flange 66 has a firstend portion 68 joined to the raised portion 24 and an opposing secondend portion 70. The device 20 includes an outer surface 33 and anopposing inner surface 34 defining an access cavity 65. As shown inFIGS. 3 and 4, a securing member 80 is attached to first flange 60adjacent end portion 64. In a similar manner, a second securing member81 is attached to second flange 66 adjacent end portion 70. In theillustrated embodiment, securing members 80 and 81 are elongated,flexible strips of adhesive tape. Midline end portions 82 and 83 of thesecuring members 80 and 81 are adhered to the inner surface 34 of thesupport device 20 while the opposing lateral ends 84 and 85 extendoutwardly laterally from the midline or contact axis 48 of the device.

Referring to FIG. 4, in use, a health care provider positions thepatient 10 to expose the perianal region 26. In the child birthingprocess, the patient 10 may be positioned in stirrups attached to adelivery table (not shown). The perianal support device 20 is then movedadjacent the gluteal cleft 13 between buttocks 14 and 15. The supportdevice 20, is positioned such that the midline 48 of the support deviceis substantially aligned with the patient's midline within the sagittalplane. Referring to FIG. 4, the support device 30 is advanced in thedirection of arrow A1 toward the anal orifice 38 (generally within thesagittal plane toward the head of the patient) to bring pressure surface30 into contact with the perianal tissues. Continued advancement of thesupport device 20 toward the anal orifice 38 applies pressure throughthe pressure surface 30 to the perianal tissues. In one aspect, thehealthcare provider places at least one finger within the access cavity65 and preferably against internal contact surface 35 to advance thedevice against the anal orifice 38. With continued pressure applied bythe healthcare provider to the access cavity 65, and/or internal contactsurface 35, fixation member 80 is extended laterally of the anal orifice38 out of the gluteal cleft 13 and releasably attached to the patient 10to at least the lateral flank 18. In a similar manner, with compressiveforce applied by the healthcare provider to support device 20, elongatefixation member 81 is extended laterally of the anal orifice 38 out ofthe gluteal cleft 13 and is secured to the patient adjacent lateralflank 19. Thus, the fixation members 80 and 81 of the system do notextend along the patient midline in the gluteal cleft 13 with thepotential for interference with the birthing process, but instead extendsubstantially laterally from the patient's midline out of the glutealcleft 13 and are attached at the patient's lateral flanks 18 and 19.

The extent of tissue deformation surrounding the anal orifice 38 whendevice 20 is applied is a function of the patient anatomy and of theamount of compressive force applied during application of the supportdevice 20. As shown in FIG. 4, the maximum extent of perianal tissueengagement inwardly on the patient in the saggital plane is shown byline 50. In one aspect, it is contemplated that pressure applied in thedirection of arrow A1 moves the anal orifice inwardly 1 cm to 3 cm. Inone embodiment, the lateral ends 84 and 85 of the fixation members 80and 81 extend beyond line 50 generally in the patient's saggital plane.The fixation members 80 and 81 exert tension forces generally in thedirection of arrows A2 and A3, respectively. This tension force isapplied to flanges 60 and 66, which are substantially rigid memberscapable of transmitting compressive forces to the raised body 24. Thetension force applied on the lateral flanks 18 and 19 of the patient 10in the direction of arrows A2 and A3 is converted to compressive forcesin the direction of arrows A4 and A5, respectively. The compressiveforces A4 and A5 are transmitted by substantially rigid flanges 60 and66 to raised body 24 and ultimately to compression surface 30 to applysupport and/or pressure to the perianal tissues in the direction ofarrow A1. It will be appreciated that the lateral components ofcompressive forces applied in A4 and A5 helps to maintain the positionof device 20 as well as tending to maintain access cavity 65 in an openposition.

As shown in FIG. 4, flanges 60 and 66 each extend for a length 76 fromthe internal contact surface 35 to their proximal ends 64 and 70,respectively. In one aspect, length 76 is greater than 5 cm but lessthan 20 cm. In the illustrated embodiment, length 76 is approximately 8cm. The flanges 60 and 66 extend away from each other to define accesscavity 65 by an internal angle 75. In one aspect, the angle 75 isbetween 30 and 140 degrees. In the illustrated embodiment, angle 75 isapproximately 90 degrees. The distance 77 between the anal orifice andthe buttocks crown 16 is less than the distance 79 between the distalend 64 of the flange 60 and the anal orifice. Thus, tension applied tofixation members 80 and 81 is transferred through substantially rigidflange 60 to exert a compressive force on pressure surface 30 in thedirection of arrow A1. Whereas, if distance 77 is greater than distance79 tension applied to fixation members 80 and 81 may pull the device 20in a direction opposite arrow A1.

It will be appreciated that with the illustrated embodiment, thehealthcare provider may reposition the device 20 and adjust thecompressive force applied through the fixation members 80 and 81 to thepressure surface 30 by releasing or adjusting the attachment between thefixation members 80 and 81 and the patient 10.

Referring now to FIGS. 5-8, there is shown a further embodiment of atissue supporting apparatus according to the present invention. Similarreferences numerals will be used to refer to components similar to thepreviously described embodiment. Device 40 comprises a base 22 having anextending raised portion 44 that, when positioned against a patient 10(see FIGS. 3 and 4), applies pressure to a perianal region 26 adjacentto an external rectal venous plexus 28 to support the perianal tissue toprevent and/or reduce the severity of hemorrhoids and other tissuedamage. The device may be secured to the patient as described above.Base 22 may be integrally formed with the raised portion, such as raisedportion 24 shown in FIG. 1, or alternatively base 22 and the raisedportion 44 may be removably connected, such as shown in FIGS. 5-8. Forexample, device 40 further includes a securing mechanism 42 operable tofix base 22 to the raised portion 44. For example, securing mechanism 42may include, but is not limited to, one or any combination of aninterlocking mechanical interface, such as a dovetail, a separatemechanical connector, or a chemically-based fixator, such as a glue.

In still a further embodiment illustrated in FIGS. 9-11, the device 90includes a raised portion 94 attached to base 22 having outwardlyextending legs 60 and 66 defining a V-shaped body. Extending from thepressure surface 30 is a plug portion 96 may be shaped and sized forinsertion within anal canal 36 of patient 25. All or a portion of plug96 may provide pressure to oppose the distension of vascular tissue,such as internal rectal venous plexus 29 and external rectal venousplexus 28, shown in FIG. 4, by placement within anal canal 36 and/oradjacent rectum 54. As such, plug portion 96 may apply pressure toprevent or reduce the severity of thrombosed internal hemorrhoids. Plugportion 96 has an enlarged distal end to resist expulsion from analcanal 36. It will be appreciated that pressure surface 30 may besubstantially rigid in comparison to the adjacent soft tissue while plugportion 96 may be formed a significantly more pliable material that isdeformable as the child 12 passes through the birth canal and out of thevaginal opening 11. The flanges 60 and 66 are configured to engage theskin of the patient laterally adjacent the anal orifice and assist inmaintaining the position thereof. It will be appreciated that inaddition to the enlarged plug 96 and flanges 60 and 66, fixation members80 and 81 may also be used to maintain the position of the device on thepatient and supply compressive force to compression surface 30.

Referring now to FIGS. 12 and 13, support device 100 is shown as afurther embodiment of the present invention. Support device 100 includesa base member 101 with a raised compression surface 130 configured forengagement with the anal orifice 38 and surrounding tissue. Thesubstantially solid base 101 has a first lateral side wall 103 and anopposing lateral side wall extending substantially parallel to eachother and parallel to the midline of the compression surface 130. Thebase has a base extension 102 that extends from the compression surface130 to the proximal end 110 a distance 104. In a preferred aspect, thedistance 104 is greater than the depth of the patient's gluteal cleft 13such that it extends outward beyond the perimeter of the patient. Theproximal end 110 includes a channel 142. A strap or other fixationmember (not shown), such as members 80 and 81, is passed through channel142. The fixation member is then secured to the patient 10 or to astationary object to secure the device 100 in position and allow thebase extension 102 to be utilized to aid in transferring force from base101 to compression surface 130. In one aspect, the base 101 is asubstantially solid, rigid member formed from a unitary material. Inanother aspect, the compression surface 130 is formed of a morecompliant material than the material forming base 101.

Additionally, flanges 60 and 66 may be positioned so as to extend awayfrom base portion 72 and/or a respective raised portions 24, 44 and 94.Further, flanges 60 and 66 may be respectively positioned at apredetermined angle 75 such that flanges 60 and 66 diverge as theyextend away from respective raised portion 24, 44 and 94. For example,in some aspects, predetermined angle 75 may be in the range of about 50degrees to about 120 degrees, while in other aspects predetermined angle75 may be in the range of about 70 degrees to about 90 degrees, while inother aspects predetermined angle 75 may comprise any angle operable toposition flanges 60 and 66 against the local anatomy of patient 10 whilepositioning the respective raised portion 24, 44 and 94 in perianalregion 26 to apply pressure to prevent or reduce the severity ofhemorrhoids.

Additionally, in the illustrated embodiments, each device 20, 40, 90,and 100 are sized and positioned with respect to patient 10 to allow forthe passage of a child through the birthing canal during childbirth. Itis contemplated that the devices may be placed to support more or lessof the perineum between the anus and vaginal opening depending on thehealth care provider's judgment and the progress of the child birthingprocess. Still further, it is contemplated that an elongated anterior toposterior device may be positioned to support at least a portion of theperianal tissue and the vaginal tissue during the labor process. It isanticipated that the supporting device will be repositioned posteriorlyaway from the vaginal opening prior to delivery of the child through thevaginal opening.

Devices 20, 40, 90, and 100 may be formed of a raised portion thatgenerally conforms to the patient's anatomy, while the base issubstantially rigid so as to resist deformation and transfer compressiveforce from fixation mechanism to raised portion. For example, the raisedportion may be formed from one or any combination of silicone or anytype of elastomeric material, while base may be formed from a plastic,vinyl, polyvinylchororide, acrylic, and/or polycarbonate material. Inother aspects, the entire device 20, 40, 90, and 100 may besubstantially rigid.

Referring now to FIGS. 14-16, there is shown another embodiment of aperianal support device 300 according to the present invention. Supportdevice 300 includes a base 310 having an external pressure surface 312.The external pressure surface 312 extends along midline axis 320 betweenfirst end 314 and opposing second end 316. A pair of opposingcompression members 330 and 340 is joined to base 310. In theillustrated embodiment, compression members 330 and 340 are integralwith and define a portion of base 310. The compression member 330includes a distal end 332 transitioning into pressure surface 312, anelongated, planar exterior side wall 334 extending from distal end 332to proximal end 336. The compression member 330 extends generally alongaxis 322 which is substantially transverse to midline axis 320 as shownin the top view of FIG. 15. In the end view of FIG. 16, it is shown thatcompression member 330 extends at an oblique angle with respect to axis326. It will be understood that axis 326 is also representative of thesagital plane of the body and midline axis 320 extends generally withinthe sagittal plane. In a similar manner, the compression member 340includes a distal end 342 transitioning into pressure surface 312, anelongated, planar exterior side wall 344 extending from distal end 342to proximal end 346. The compression member 340 extends generally alongaxis 324 which is substantially transverse to midline axis 320 as shownin the top view of FIG. 15. In the end view of FIG. 16, it is shown thatcompression member 340 extends at an oblique angle with respect to axis326. It will be appreciated that in the illustrated embodiment,compression member 330 extends at an oblique angle substantially equalto the oblique angle at which compression member 340 extends withrespect to axis 326.

The perianal support device 300 has an internal contact surface 313defined along the midline 320 opposing the exterior pressure surface312. It will be understood that a health care provider may applypressure to the contact surface 313 to move the support device 300 intothe operative position and/or apply additional pressure to compress atleast some perianal tissues. The compression member 330 includes aninterior wall 338 while compression member has an opposing interior wall348 generally facing interior wall 338. The interior walls 338 and 348along with internal contact surface 313 define an access cavity 350within the perianal support device. As shown in FIG. 16, theconfiguration of the base 310 as described above results in a generallywedge shaped device. Still further, with the inclusion of the accesscavity 350, the base 310 has a substantially V-shaped configuration withthe pressure surface 312 defined at the apex of the V and thecompression members 330 and 340 forming the legs of the V.

Referring now to FIG. 17, there is shown an embodiment of a supportsystem 400 according to another aspect of the present invention. Supportsystem 400 includes perianal support device 300 as previously describedwith respect to FIGS. 14-16. A compliant pad 410 is adhered to thesupport device 300 across the majority of the pressure surface 312. Asillustrated, a first portion 414 of the complaint pad 410 extends alongand is adhered to distal portion 332 of compression member 330. In asimilar manner, second portion 416 extends along and is adhered todistal portion 342 of compression member 340. In one embodiment, thecompliant pad 410 is a sterile gauze pad. In another embodiment, thecompliant pad 410 includes an internal cushioning structure, such aspolyurethane, silicon, rubber, foam, cotton, etc, with a non-abrasiveskin contact surface. In one embodiment, the compliant pad is die cutfrom 1776 and 1772 stock materials from 3M. Then bonding the resultinglaminate on to the compression surface as the 1772 material has anadhesive back. In another embodiment, compliant pad 410 is an absorbentmaterial adapted to absorb bodily fluids. It will be appreciated thatthe compliant pad 410 may make placement and maintenance of the supportdevice 300 more comfortable for the patient. In addition, the surface ofthe pad 410 is configured to frictionally engage the patient's perianaltissue to inhibit movement between the support device 300, particularlythe pressure surface 312 and the patient. In still a further aspect,compliant pad 410 includes a treating compound. The treating compound isdisposed within the pad, applied on the surface, or a combination ofboth. Treating compounds useful for combination with pad 410 include,but without limitation to other compounds, antibacterial compounds,antibiotic compounds, sclerants, antimicrobial compounds,anti-inflammatory compounds, anti-fungal agents, anti-itching agents,humicants, moisture absorbing agents, gas absorbing agents, bufferingagents for pH control, drying agents and the like and coagulants. In yeta further embodiment, pad 410 is not fixed to device 300 but is insteadpositioned on the patient in advance of positioning device 300 or isloosely held to device 300 has it is applied to the body. In thisembodiment, device 300 maintains the position of the pad 410 relative tothe patient's body and in particular the anal orifice.

The support system 400 also includes a mechanism for securing theposition of the perianal support device 300. An elongated fixationmember 420 is joined to internal surface 338 of compression member 330.At least a portion of surface 422 of fixation member 420 has an adhesivecoating adapted for joining to a fixed object. In a similar manner,elongated fixation member 430 is fixed to the internal surface 348 ofcompression member 340. Likewise, surface 433 includes an adhesivecoating that can fix the elongated member to another object. In oneembodiment, the adhesive coating is adapted for releasably adhering to apatient's skin. In another embodiment, the adhesive is adapted forjoining to an inanimate object or to itself. In this manner, thefixation members 420 and 430 can fix the position of the support device300 relative to the operating table or other fixture near the patient.In the illustrated embodiment, the elongated fixation members 420 and430 are formed of flexible tape. Further, while they have been describedseparately, in one embodiment, the elongated fixation members are formedby a continuous piece of material joined in the middle to the perianalsupport device 300.

Referring now to FIGS. 18 and 19, there is shown a support system 500adapted to provide perianal support to a human patient. Support system500 includes the perianal support member 300 and compliant pad 400 asdiscussed above. Complaint pad 410 is oriented to extend along themidline axis 320 to thereby form a contact surface oriented along themidline axis. In the illustrated embodiment, the midline axis alsocorresponds to the apex of the V-shaped support member. As analternative to the embodiment illustrated in FIG. 17, the support systemof FIG. 18 includes a pair of two part securing mechanisms. The firstsecuring mechanism 510 includes an elongated fixation member 520 joinedto the support device 300 at medial end 521 and extending generallylaterally away from midline axis 320 in the direction of axis 322 towardlateral end 529. The fixation member includes a first half of areleasable fastening system on surface 522, such as a hook and loopsystem or a releasable adhesive system. The second component of thesecuring mechanism 510 includes an anchor pad 524. In the illustratedembodiment, anchor pad 524 has a generally square shape that is shorterin length and wider than elongated fixation member 520. The shape of theanchor pad is shown for illustration purposes and may take any form thatis suitable for fixing to a patient or inanimate object, as well asjoining to the elongated fixation member. Anchor pad 524 includes afirst surface 528 having an adhesive surface adapted for joining to thepatient's skin or some inanimate object. The opposing surface 526includes the second half of the releasable fastening system. In asimilar manner, the second securing mechanism 512 includes an elongatedfixation member 530 joined to the support device 300 at medial end 531and extending generally laterally away from midline axis 320 in thedirection of axis 324 toward lateral end 539. The fixation memberincludes a first half of a releasable fastening system on surface 532,such as a hook and loop system or a releasable adhesive system. Thesecond component of the securing mechanism 512 includes an anchor pad534. In the illustrated embodiment, anchor pad 534 has a generallyrectangular shape that is shorter in length and wider than elongatedfixation member 530. Anchor pad 534 includes a first surface 538 havingan adhesive surface adapted for joining to the patient's skin or someinanimate object. The opposing surface 536 includes the second half ofthe releasable fastening system.

As shown more clearly in FIG. 19, each compression member 330/340 has alength L1 and extends away from each other by an angle A1. The maximumlateral distance of the access cavity is defined by the distance D1extending between distal ends 536 and 546. In one embodiment, L1 isgreater than 4 cm in length. In a preferred aspect, L1 is approximately8 cm. In one embodiment angle A1, is between 140 degrees and 30 degrees.In the illustrated embodiment, angle A1 is approximately 80 degrees. Inone embodiment, the maximum lateral distance D1 of the access cavity isgreater than 4 cm. In the illustrated embodiment of FIG. 19, the maximumlateral distance is approximately 10 cm. It will be understood thatwhile compressive members 330/340 are sufficiently rigid to transmitcompressive force toward the pressure surface, in one embodiment theyare flexible, at least laterally, to bow or bend in response to forceapplied to the fixation members 520/530. In contrast, the anterior toposterior distance of the pressure surface 312 between first end 314 andsecond end 316 is approximately 5 cm in the illustrated embodiment (FIG.14). This midline length between the first end 314 and the second end316 of the device 300 can be adjusted in some embodiments depending onthe amount and extent of perianal tissue that needs to be supported.

Referring now to FIGS. 19 and 20, the support system 500 is illustratedin association with the perianal tissue of a patient 10. The patient 10is shown in partial cross section to illustrate a portion of the rectum54, anal canal 36, anal orifice 38, internal venous plexus 29, pectinateline 37 (also known as the dentate line), and external venous plexus 28.The patient's buttocks 14 and 15 are shown with the crown of thebuttocks 16 and 17, respectively, laterally adjacent the perianalregion. The buttocks 14 and 15 extend laterally beyond crowns 16 and 17toward lateral flanks 18 and 19, respectively. The depth in the saggitalplane of the gluteal cleft 13 from the anal orifice 38 to the buttockscrown 16 is shown by distance D2. The lateral flanks 18 and 19 mayinclude, for example but without limitation, all or a portion of thebuttocks, hips, or upper thigh of the patient.

In use, a health care provider positions the patient to expose theperianal region. In the child birthing process, the patient may bepositioned in stirrups attached to a delivery table. Anchor pads 534 and524 are adhered to the patient's skin on the lateral flanks 18 and 19,respectively. As best seen in FIG. 20, the anchor pads 524 and 534 arepositioned on the lateral flanks 18 and 19 laterally adjacent thejunction of the femur with the pelvis. The perianal support device 300is then moved adjacent the gluteal cleft 13 between buttocks 14 and 15.The midline 320 of the support device is generally aligned with thepatient midline within the sagittal plane. The support device isadvanced in the direction of arrow A1 toward the anal orifice 38(generally within the sagittal plane) to bring pad 410 into contact withthe perianal tissues. Continued advancement of the support device towardthe anal canal applies pressure through the pressure surface 312 and pad410 to the perianal tissues. In one aspect, the healthcare providerplaces at least one finger within the access cavity 350 and preferablyagainst internal contact surface 313 to advance the device against theanal orifice. In another aspect, an instrument having complimentaryengagement surface to at least a portion of the access cavity 350 isused to apply pressure to the device 300. With continued pressureapplied by the healthcare provider to the access cavity 350, and/orinternal contact surface 313, elongated fixation member 520 is extendedlaterally of the anal orifice 38 out of the gluteal cleft 13 andreleasably attached to anchor pad 524 with at least lateral end 529extending adjacent lateral flank 19. In a similar manner, withcompressive force still applied by the healthcare provider to supportdevice 300, elongate fixation member 530 is extended laterally of theanal orifice 38 out of the gluteal cleft 13 and is secured to anchor pad534 with at least lateral end 539 extending adjacent lateral flank 18.Thus, the fixation members 520 and 530 of the system 500 do not extendalong the gluteal cleft 13 with the potential for interference with thebirthing process but instead extend substantially laterally from thepatient's midline out of the gluteal cleft 13.

The extent of tissue deformation surrounding the anal orifice 38 is afunction of the patient anatomy and of the amount of compressive forceapplied during application of the support device 300. In one aspect, thehealth care provider makes initial contact with anal orifice 38 and thenapplies pressure in the saggital plane (generally toward the patient'shead) to advance the device 1 cm to 3 cm. This advancement of the deviceapproximately 1 cm to 3 cm compresses the perianal tissue and therebysupports the tissue to inhibit distention as the patient pushes duringthe birthing process. It will be appreciated that with the illustratedembodiment, the healthcare provider may reposition the device and adjustthe compressive force applied through the compression members 330 and340 to the pressure surface 312 by releasing or adjusting the attachmentbetween the anchor pads 524/534 and the fixation members 520 and 530

In an alternative approach, the pad 410 and pressure surface 312 arepositioned in engagement with the anal orifice with little if anycompressive force applied to deform the perianal tissue. The supportdevice is then secured in position as described above. With thistechnique, the support device will resist movement of the device in adirection generally away from the patient's head and will therebysupport the perianal tissue to maintain its position.

As shown in FIG. 19, the distance D2 between the anal orifice and thebuttocks crown 16 is less than the distance D3 between the distal end546 of compression member and the anal orifice. The distance D3represents the length or extent of the compression member 340 asmeasured in the saggital plane. In one aspect, this length is greaterthan 3 cm. In another aspect, as shown, the distance D3 is approximately6 cm. Thus, tension applied to fixation member 530 is transferredthrough compression member 340 to exert a compressive force on pressuresurface 312. As previously described above with respect to FIG. 4,tension force applied to the flexible fixation members in the directionof arrows A2 and A3 are converted to compressive forces A4 and A5,respectively resulting in compression at the pressure surface 312 in thedirection of arrow A1 directed inwardly toward the anal orifice.

Referring now to FIG. 20, with system 500 in position, a healthcareprovider is allowed to position one or both hands 600 within the accesscavity 350 extending into the gluteal cleft. In this manner, the hands600 may be below the lowest portion 9 of the vaginal opening 11 as thehead of the baby 12 passes out of the vagina. Thus, the hand within theaccess cavity 350 is positionable less than 1 cm from the mother'svaginal opening or perineum so the healthcare provider may support thehead of the baby as is it is being born. The position of second end 316of the support device 300 also allows access to the tissue immediatelybelow the vaginal opening 11 in the event an obstetric maneuver, such asan episiotomy, manipulation of the fetus, etc., is necessary. Further,as discussed above, in one aspect the support device 300 is quicklyrepositioned or removed by releasing at least one of the straps from theanchor pads, an obstetric maneuver is performed, the device 300 isrepositioned in a supporting position adjacent the anus and theanchoring straps are repositioned on the anchor pads.

In one embodiment, the support system is formed of biocompatiblematerial suitable for contact with human tissue. Moreover, in oneembodiment, the device is provided sterile in a package for single useapplication on a patient, although reusable devices according to thepresent teachings are also disclosed in the present description. In thesingle use type of embodiment, the device is cost effectivelymanufactured such that it is discarded after use. For example, thedevice 300 is formed by of a substantially rigid polycarbonate material.In one aspect, the device 300 is injection molded to substantially itsfinal V-shaped form. The compliant pad 412 is then applied to the apexand fixation members 520 and 530 are joined to the compression membersvia an adhesive. It is contemplated that fixation members 520 and 530may be riveted, snapped or otherwise fixedly attached to the compressionmembers. Still further, in a different embodiment, fixation member 520is passed through a channel or other opening associated with thecompression members to loosely and/or removably join the fixation memberto the compression device. In one aspect, compression member 520 is aloop portion of a hook and loop fastening system, such as sold under thetradename VELCRO.

It is contemplated that in other embodiments, the device 300 is formedby compression molding, transfer molding, reactive injection molding,extrusion, blow molding, casting, heat-forming, machining, deforming asheet, bonding, joining or combinations thereof. In other embodiments,suitable materials for device 300 include polymers, metals, ceramics orcombinations thereof. The materials can be or include alone or incombination: hard solids, soft solids, tacky solids, viscous fluid,porous material, woven fabric, braided constructions, or non-woven mesh.Examples of polymers include polyethylene, polyester, Nylon, Teflon,polyproplylene, polycarbonate, acrylic, PVC, styrene, PEEK, etc.Examples of ceramics include alumina, zirconia, carbon, carbon fibers,graphites, etc. Examples of suitable metals include titanium, stainlesssteel, cobalt-chrome, etc.

It is contemplated that in still further embodiments, the complaint pad412 can be made from or includes at least one of the following, eitheralone or in combination: woven fabric, non-woven mesh, foam, film,porous sheet, and non-porous sheet. At least the device 300 andcompliant pad 412 are sterilized by know techniques; such as ethyleneoxide gas, gas plasma, electron-beam radiation or gamma radiation. Suchmaterials are available from various suppliers such as 3M. In a similarmanner, the fixation members or straps may be formed of hook and loopfastening systems available from 3M. Adhesive fixation systems may beadhesive a Rayon woven tape on a liner (1538L from 3M). The tape mayinclude liners to prevent premature tape adhesion. In one embodiment,the liners include a cut between the midline end adjacent device 300 andthe lateral end. During initial placement, the device is pushed againstthe anus with a first hand. The opposite hand spreads the butt checkaway from the device while the first hand pushes the base to get furthercompressive penetration in the gluteal cleft. The hands are switch andthe steps are repeated on the opposite butt check. After position thedevice, the liners adjacent the device 300 are sequentially removed andadhered to the medial portion of the buttocks for provisionalpositioning of the device. Once the device is provisionally positioned,the first lateral liner is removed and with pressure applied to thedevice, the lateral tape segment is adhered to the patient in a finalsupporting position to supply compressive force to the device. This stepis repeated on the opposite side for final fixation.

The present invention also contemplates a kit that includes one or moreof the components described above provided in a package. In oneembodiment, the kit includes at least a sterilized perianal supportdevice. In another aspect, the kit further includes an anchoringassembly as described above. In this embodiment, the anchoring assemblymay be preassembled with the perianal support device as shown in thedrawings or may be provided unassembled. In the unassembled kit, ahealth care provider will remove the support device and anchoringassembly from the packaging and assembly the support device with theanchoring assembly. As set forth above, the anchoring assembly may beadhered to the support assembly near the patient or the support assemblymay include fastening members or apertures to receive elements of theanchoring assembly. For example, the support device may include anaperture and a portion of a flexible strap may be threaded through theaperture to join the two components. In still a further embodiment, thekit includes a treating compound to apply to the patient. In one suchembodiment, the treating compound is provided in a separate package. Inan alternative embodiment, the treating compound is applied to orincorporated into the support device on the perianal contact surface.

The foregoing outlines features of several embodiments so that thoseskilled in the art may better understand the aspects of the presentdisclosure. Those skilled in the art should appreciate that they mayreadily use the present disclosure as a basis for designing or modifyingother processes and structures for carrying out the same purposes and/orachieving the same advantages of the embodiments introduced herein.Those skilled in the art should also realize that such equivalentconstructions do not depart from the spirit and scope of the presentdisclosure, and that they may make various changes, substitutions andalterations herein without departing from the spirit and scope of thepresent disclosure. Furthermore, although elements of the describedembodiments may be described or claimed in the singular, the plural iscontemplated unless limitation to the singular is explicitly stated.Additionally, all or a portion of any aspect and/or embodiment may beutilized with all or a portion of any other aspect and/or embodiment.

1. An apparatus, comprising: a perianal support member having a firstside and an opposite second side, the first side including a pressuresurface configured for engagement with tissue adjacent an anal orifice;and a pair of substantially rigid sidewalls extending from said secondside, the sidewalls each having exterior surfaces and interior surfaces,the interior surfaces defining an access passage to the second side. 2.The apparatus of claim 1, wherein the exterior surfaces of the sidewalls define an external angle therebetween, said external angle lessthan 120 degrees.
 3. The apparatus of claim 2, wherein said externalangle is less than 90 degrees.
 4. The apparatus of claim 3, wherein saidexternal angle is between 90 and 60 degrees.
 5. The apparatus of claim4, wherein said external angle is between 80 and 60 degrees.
 6. Theapparatus of claim 1, wherein said internal walls define an internalangle therebetween, said internal angle less than 120 degrees.
 7. Theapparatus of claim 6, wherein said internal angle is less than 90degrees.
 8. The apparatus of claim 7, wherein said internal angle isbetween 90 and 60 degrees.
 9. The apparatus of claim 8, wherein saidexternal angle is between 80 and 60 degrees.
 10. The apparatus of claim1, wherein said external side walls are generally parallel to therespective internal side walls.
 11. The apparatus of claim 1, whereinsaid external side walls and said internal walls define a substantiallyV-shaped perianal support device.
 12. The apparatus of claim 1, whereinsaid second surface is within 2 cm of said pressure surface.
 13. Theapparatus of claim 1, further including a flexible anchor member joinedto at least one of said side walls.
 14. A perianal support device,comprising: a compression body having compression surface configured forengagement with at least a portion of the perianal tissue of a patient,said compression surface oriented in a first direction; and acompression member having a proximal portion and a distal portion, saidcompression member operatively joined to said compression body adjacentsaid distal portion and extending therefrom in a second direction tosaid proximal portion, said second direction generally transverse tosaid first direction, said compression member configured to transmitcompressive force applied adjacent said proximal portion to saidcompression surface.
 15. The device of claim 14, further including atleast a second compression member joined to said compression body. 16.The device of claim 15, wherein said second compression member extendsin a third direction substantially transverse to said first directionand at an angle with respect to said second direction.
 17. The device ofclaim 16, wherein said angle is between 130 and 30 degrees.
 18. Thedevice of claim 17, wherein said angle is between 100 and 70 degrees.19. The device of claim 14, wherein said compression member includes anengagement surface for joining to an anchoring member.
 20. A method,comprising: providing a support member having a pressure surfaceconfigured for engaging the perianal area of a patient and an elongatedcompression member; positioning the pressure surface proximate theperianal area of a patient and the compression member extendingoutwardly beyond the crown of the buttocks; and applying pressure to thecompression member to direct pressure through the pressure surfaceagainst the perianal area of the patient.
 21. The method of claim 20,further including securing at least the compression member againstmovement.
 22. The method of claim 21, wherein the securing includesadhering a portion of an elongated member to the patient.
 23. The methodof claim 21, wherein the securing includes affixing an anchor to thepatient and joining a portion of an elongated member to the anchor. 24.The method of claim 20, further including providing an elongatedfixation member joined to the compression member and said applyingpressure includes tensioning the elongated fixation member.
 25. Themethod of claim 24, further including securing the elongated fixationmember to the patient after said tensioning.
 26. The method of claim 25,wherein said securing includes moving the elongated fixation memberlaterally away from the anal orifice and fixing to a lateral flank ofthe patient.
 27. A method of inhibiting perianal tissue damage duringchildbirth, comprising: positioning a perianal support device in contactwith at least a portion of the perianal tissue of the patient prior todelivery of a child; positioning a compression member associated withthe support device to extend outwardly in the saggital plane beyond agluteal cleft; securing the position of the compression member relativeto the perianal tissue, to thereby maintain the position of the perianalsupport device.
 28. The method of claim 27, wherein said positioning ofthe perianal support device in contact with at least a portion of theperianal tissue is performed concurrently with said positioning acompression member.
 29. The method of claim 27, wherein said securingincludes moving an elongated fixation member connected to thecompression member to a securing position.
 30. The method of claim 29,wherein moving said elongated fixation member includes extending theelongated fixation member generally laterally away from the perianaltissue.
 31. The method of claim 30, further comprising securing theelongated fixation member to a lateral flank of the patient.
 32. Themethod of claim 31, wherein said securing includes adhering at least aportion of the elongate fixation member to the patient's skin.
 33. Themethod of claim 31, wherein said securing includes engaging the elongatefixation member with an anchor.
 34. The method of claim 33, furtherincluding securing an anchor to the patient prior to said engaging. 35.A system for perianal tissue support, comprising: a support body havinga perianal tissue pressure member extending along a midline axis; and alateral anchoring assembly joined to said body and extending away fromsaid body in a direction substantially transverse to the midline axis.36. The system of claim 35, wherein said body includes a least onelateral side wall spaced from the midline axis, said lateral side wallconfigured for engagement with tissue disposed laterally adjacent theperianal region.
 37. The system of claim 35, wherein said pressuremember includes first length extending along the midline axis and saidbody further includes a compression member having a second lengthextending along a second axis, said second length greater than saidfirst length.
 38. The system of claim 35, wherein said second axis isdisposed substantially transverse to said midline axis.
 39. An apparatusto support perianal tissue of a patient, comprising: a perianal supportdevice configured to be received within a portion of a gluteal cleftextending generally from a vagina to the coccyx, the gluteal cleftextending generally in a sagittal plane, the support device adapted toengage at least a portion of the perianal tissue of the patient; and ameans for securing the perianal support device in a support position onthe patient, said means for securing configured to extend substantiallyperpendicular to the sagittal plane.
 40. The apparatus of claim 39,wherein said means for securing includes a flexible member forreleasably joining to the patient.
 41. The apparatus of claim 39,wherein said perianal support device includes an elongated body portionextending for a length in the saggital plane, the gluteal cleft having adepth, said length greater than said depth.
 42. The apparatus of claim39, wherein said perianal support device is wedge shaped.
 43. Theapparatus of claim 42, wherein said perianal support device defines aninternal access cavity.
 44. The apparatus of claim 43, wherein saidperianal support device is V-shaped.
 45. The apparatus of claim 39,wherein the means for securing includes a first portion attached to theperianal support device and an anchor spaced from the perianal supportdevice, the first portion engagable with the anchor.
 46. A supportdevice for use on a patient, comprising: a body configured for at leastpartial placement in the cleft of the buttocks, the cleft having a depthmeasured in the sagittal plane of the patient, the body having a contactsurface configured to support a perianal region and a compression memberextending from said body, said compression member extending a distancemeasured in the saggital plane, said distance greater than said depth.47. The device of claim 46, wherein said compression member extendssubstantially along the sagittal plane of the patient.
 48. The device ofclaim 46, wherein said compression member extends at a first angle withrespect to said sagittal plane of the patient.
 49. The device of claim48, further including a second compression member extending from saidbody, said second compression member extending at a second angle withrespect to the sagittal plane complimentary to the first angle.
 50. Thedevice of claim 46, wherein said compression member is integral withsaid body.
 51. The device of claim 49, wherein said body, compressionmember and second compression member form a V-shape.
 52. The device ofclaim 51, wherein the V-shape has an apex and a pair of legs extendingfrom the apex, said contact surface is positioned adjacent the apex ofthe V-shape and the pair of legs extending from the apex are thecompression members.
 53. The device of claim 46, further including ananchor system for maintaining the position of the contact surface in theperianal region, said anchor system operatively engaged with saidcompression member.
 54. The device of claim 53, wherein said anchorsystem includes a flexible member.
 55. The device of claim 54, whereinsaid anchor system includes a patient fixation component configured forattachment to the patient.
 56. The device of claim 55, wherein saidpatient fixation component includes an adhesive segment to adhere atleast a portion of the anchor member to the patient's skin.
 57. Thedevice of claim 55, wherein a first component of the patient fixationcomponent is an adhesive pad adapted to adhere to the patient and asecond component is joined to said compression member and removablyattachable to said first component.
 58. The device of claim 57, whereinsaid first component includes a first half of a hook and loop fasteningsystem and said second component includes an opposing half of the hookand loop fastening system such that the first component may be removablyconnected to the second component.
 59. A perianal support device,comprising: a perianal support body having a pressure surface configuredto engage perianal tissue; and a means for applying pressure, said meansfor applying pressure having a first portion engaged to the support bodyand a second portion extending away from the support body, said meansfor applying pressure configured to force the pressure surface to pressagainst the perianal tissue.
 60. The device of claim 59, wherein saidmeans includes a substantially rigid compression member extendingoutwardly from the support body.
 61. The device of claim 60, furtherincluding a tension member joined to the compression member.
 62. Thedevice of claim 61, wherein the tension member includes a securingmechanism for anchoring the tension member.
 63. The device of claim 62,wherein the securing mechanism includes an adhesive.
 64. The device ofclaim 62, wherein the securing mechanism includes at least one portionof a hook and loop fastening system.
 65. A kit for providing perianalsupport, the kit comprising: a perianal support body having a pressuresurface configured to engage perianal tissue, the pressure surfacehaving a length; and a compression system having a first portionconfigured for engagement with the support body and a second portionspaced from the support body greater than said length, said compressionsystem configured to load the pressure surface into compressive contactwith the perianal tissue.
 66. The kit of claim 65, wherein thecompression system includes at least one strap pre-assembled with thesupport body.
 67. The kit of claim 65, wherein the compression system isprovided in the kit separate from the support body.
 68. The kit of claim65, further including a treating compound.
 69. The kit of claim 68,wherein the treating compound is provided in a separate package withinthe kit.
 70. The kit of claim 68, wherein the treating compound isprovided on the support body within the kit.